NASDAQ:DMAC DiaMedica Therapeutics Q1 2025 Earnings Report $4.11 -0.06 (-1.44%) As of 01:38 PM Eastern ProfileEarnings HistoryForecast DiaMedica Therapeutics EPS ResultsActual EPS-$0.18Consensus EPS -$0.18Beat/MissMet ExpectationsOne Year Ago EPS-$0.14DiaMedica Therapeutics Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ADiaMedica Therapeutics Announcement DetailsQuarterQ1 2025Date5/13/2025TimeAfter Market ClosesConference Call DateWednesday, May 14, 2025Conference Call Time8:00AM ETUpcoming EarningsDiaMedica Therapeutics' Q2 2025 earnings is scheduled for Wednesday, August 6, 2025, with a conference call scheduled on Thursday, August 7, 2025 at 8:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by DiaMedica Therapeutics Q1 2025 Earnings Call TranscriptProvided by QuartrMay 14, 2025 ShareLink copied to clipboard.PresentationSkip to Participants Operator00:00:00Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter twenty twenty five Conference Call. An audio recording of the webcast will be available shortly after the call today on DiaMedica's website at www.diamedica.com in the Investor Relations section. Before DiaMedica proceeds with its remarks, please note that the company will be making forward looking statements on today's call. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these statements. More information, including factors that could cause actual results to differ from projected results, appears in the section entitled Cautionary Note Regarding Forward Looking Statements in the company's press release issued yesterday and under the heading Risk Factors in the company's most recent annual report on Form 10 ks and most recent quarterly report Form 10 Q. Operator00:01:00DiaMedica's SEC filings are available on the SEC's website, www.sec.gov, and on its website, DiaMedica.com. Please also note that any comments made on today's call speak only as of today, 05/14/2025, and may no longer be accurate at the time of any replay or transcript rereading. DiaMedica disclaims any duty to update its forward looking statements. Following the prepared remarks, the phone lines will be open for questions. I would now like to turn you over to your host for today's call, Mr. Operator00:01:38Rick Pauls, DiaMedica's President and Chief Executive Officer. Mr. Pauls? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:01:45Thank you, operator. Hello, everyone, and welcome to our first quarter twenty twenty five conference call. I am joined this morning by Scott Kellen, our Chief Financial Officer. Doctor. Lorianne Mascioka is currently on short term medical leave and we hope she gets well soon. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:02:00We're happy to be here today to update you on the progress on our two clinical development programs. It has only been a short interval since our last update, thus I will keep my remarks brief. That said, I'm pleased to report that we continue to make substantial progress in both of our clinical development programs. I'll start with an update on our preeclampsia program. Building upon the significant accomplishments of this program within a very short timeframe, as we discussed in March, we're pleased to be able to disclose that we believe Part 1a of our Phase two investigator sponsored preclampsia trial is very close to identifying a target dose, to move forward within in Part 1b. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:02:41Dose selection will be guided primarily by a few key data points, which we expect to be sharing in our upcoming preliminary top line results from the Part 1a proof of concept portion of the trial. These key data points include: one, safety and tolerability, including results of a placental transfer analysis Two, the amount of decrease in systolic and diastolic blood pressure levels. And three, changes in uterine and placental blood flow as assessed by the Doppler ultrasound measurement of the Uterine Artery Pulcability Index. This measure is important as reductions in the pulsatility index may suggest decreased downstream resistance and improved uterine and placental blood flow, which could also be an indication of disease modifying. Currently we expect to be in a position to release those preliminary top line results between the second half of June and the July. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:03:39The final timing will be primarily dependent on the schedules at the outside laboratories running the various tests, including the pharmacodynamic biomarkers and the assay, which will be used to determine if DM199 crosses the placental barrier. One additional update. May is preeclampsia awareness month, and we will be sponsoring a preeclampsia key opinion leader call on May 28 at 8AM Eastern. Compared to other therapeutic areas like oncology, which have advanced more rapidly in recent years, the treatment of pregnancy complications remains outdated and is not well understood. No FDA approved treatments exist for preeclampsia despite the growing burden of this disease. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:04:24To our knowledge, DM199 is the only novel agent currently being studied in pregnant women with preeclampsia. With this KOL event, we will continue our work to educate investors, physicians, and other interested parties on preeclampsia as a disease and the current state of treatment. With this background, we will also discuss the design of our current Phase two trial of DM199 in preeclampsia. Turning briefly to our stroke program. Enrollment is moving ahead steadily. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:04:54We're pleased to announce that participant enrollment now is between the twentieth and twenty fifth percentile mark of patients enrolled for the interim analysis. Our next enrollment update will be at the fiftieth percentile mark. We believe that our efforts over the past year to engage with sites to promote communications between the sites and to simplify study logistics have been important in driving the recent uptick in enrollment. Accordingly, we reiterated our guidance that the interim analysis on those first two hundred participants will be completed in the first half of twenty twenty six. I would also note for you that we have engaged an experienced stroke neurologist to support site engagement during Lori Ann's leave in order to maintain our enrollment momentum in the REMEDY two trial. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:05:43This individual has spent over ten years treating stroke patients at a major US research center and also has five years of recent biotech drug development experience. He has been doing a tremendous job connecting with and maintaining our relationships with sites and supporting our recent enrollment momentum. Now I'd like to hand the call over to Scott Kellen to review this quarter's financial results. Scott KellenCFO & Secretary at DiaMedica Therapeutics00:06:06Thanks Rick, and good morning everyone. As the operator mentioned, we announced our first quarter twenty twenty five financial results and filed our quarterly report on Form 10 Q yesterday after the markets closed. These documents are both available on either the DiaMedica or the SEC websites. As of 03/31/2025, we reported a total combined cash and investments of 37,300,000.0 current liabilities of $4,700,000 and working capital of $32,800,000 This compares to a total combined cash and investments of $44,100,000 5 point 4 million dollars in current liabilities and $39,200,000 in working capital as of 12/31/2024. The decreases in combined cash and investments and in working capital were due primarily to the net cash used to fund our operations. Scott KellenCFO & Secretary at DiaMedica Therapeutics00:07:02Our net cash used in operating activities for the first quarter of twenty twenty five was $7,100,000 compared to $6,700,000 for the first quarter of twenty twenty four. The increase in cash used in operating activities resulted primarily from our increased net loss, partially offset by changes in operating assets abilities occurring during the current year period. We anticipate that our current cash and investments provides us a runway into Q3 of twenty twenty six. Our research and development expenses increased to $5,700,000 for the three months ended 03/31/2025, up from 3,700,000.0 for the three months ended 03/31/2024. The increase was due primarily to cost increases resulting from the continuation of our REMEDY two clinical trial, including our global expansion, increased manufacturing development activity, and the expansion of our clinical team during 2024. Scott KellenCFO & Secretary at DiaMedica Therapeutics00:08:05Now these increases were partially offset by cost reductions related to in use study work performed and completed in the prior year period. We expect that our R and D expenses will moderately increase in future periods relative to our recent prior periods, as we continue our REMEDY two trial, including the global expansion and our continued expansion of our DM199 clinical development program in preeclampsia. Our general and administrative expenses were $2,500,000 and $2,100,000 for the three months ended 03/31/2025 and 2024 respectively. This increase resulted primarily from additional non cash share based compensation expense recognized as a result of the approval of an extension of the post termination exercise period for stock options held by a retiring member of our Board of Directors. We expect G and A expenses to remain steady in future periods as compared to recent prior periods. Scott KellenCFO & Secretary at DiaMedica Therapeutics00:09:06Our net other income was $443,000 for the three months ended 03/31/2025, compared to 597,000 for the three months ended 03/31/2024. This decrease was driven by reduced interest income recognized during the current year period related to lower average marketable securities balances during the current year period as compared to the prior year period. With that, let me ask the operator to open the lines for questions. Operator00:09:38Thank you so much. Ladies and gentlemen, we will now begin our question and answer session. And And your first question comes from Thomas Flaten with Lake Street. Please go ahead. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:10:10Good morning. I appreciate taking the questions. Hey Rick, just to clarify, the laboratory test results that seem to be the variable in terms of readout between June and July. Is that primarily the test for DM199 crossing the placental barrier so in the umbilical cord or is there something else there that we should be aware of? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:10:31Yes, Thomas. Yes, absolutely. So that's the main item is going to be the placental transfer. So we have an assay that we're just having finalized in terms of getting to lower limits of detection. And so it's just a question of time for them to run it. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:10:47We want to at least give a range today in terms of when we anticipate the results. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:10:52Makes sense. And then I see you mentioned that you're expecting to start Part 1b in Q3. What are the triggers for Part two and three? So the expected management and the fetal growth restriction components of the study. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:11:08So I'll start off with the fetal growth restriction. So if we see dilation of the intrauterine arteries, our investigators are prepared to move ahead with that cohort and then we'll have more to talk about the part two when we daylight the results here in the coming weeks. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:11:29Got it. Excellent. I appreciate you taking the questions. Thank you. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:11:35Thanks Thomas. Operator00:11:38Your next question comes from Matthew Caulfield with H. C. Wainwright. Please go ahead. Matthew CaufieldVP - Senior Healthcare Analyst at H.C. Wainwright & Co.00:11:44Hi, good morning, guys. Thanks for taking our question. I was wondering if you could speak to anticipated read through or any derisking between the initial preeclampsia data and how that profile could translate to AIS development and the REMEDY two trial? Thanks again. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:12:02Sure. I mean, I'll start off by saying that these are definitely two very unique indications, but will add that a positive effect here in preeclampsia will just be another confirmation that this protein is active. And I would also mention around that we've previously talked about the fact that there are two forms of this protein in Asia that are being used. So the form of the protein isolated from human urine that today is treating close to a million patients per year for acute ischemic stroke. And then there's also form the protein isolate from pig pancreas in both Japan and China. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:12:42And we've been able to track down about 10 publications with that form of the protein to treat preeclampsia. So I think it will just be very encouraged and that we have an active protein and what we're seeing in some of the validation rationale for going into both of these indications is the, what we'll call the crude forms in Asia today. Matthew CaufieldVP - Senior Healthcare Analyst at H.C. Wainwright & Co.00:13:05Thanks a lot. Appreciate guys. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:13:08Thank you. Operator00:13:10Your next question comes from Chase Knickerbocker with Craig Hallum. Please go ahead. Chase KnickerbockerSenior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC00:13:17Good morning. Thanks for taking the questions. Rick, just on stroke, be good to kinda get some incremental details on, on enrollment. I mean, maybe just kinda starting out with those high volume or potential high volume centers. You know, can you kinda give us an update on what percentage of kind of those high volume accounts are now, at that one to two per month that you want to see? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:13:43I would add that as we had kind of talked on past calls, we really did think that there would be a small number of sites in particular in The U. S. That would drive enrollment. And as we're starting to build some momentum that's clearly what we're starting to see. So some of these high enrolling sites are seeing the one to two patients per site per month. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:14:04And so we're working on building momentum and then really working hard on some of those other sites to expand the relationship here to encourage. But I say currently we are above our plan here now and we're encouraged with momentum that's being built. Chase KnickerbockerSenior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC00:14:23So maybe just an update on overall centers as well as, know, again, it's only been a couple months here, have we expanded that past 30? Then maybe on the geographic footprint of those centers, have we started to see some international enrollment come in? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:14:39Yes. So we're currently in mid-30s and keeping in mind that there are sites now that are not performing that we're shutting down. And so we're really again focusing on the high enrolling sites. We also have sites in Georgia that have been performing very well. That's where that is the country of Georgia. Chase KnickerbockerSenior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC00:14:59Yeah, yeah, got it. And just kind of I guess summon all this up. First half twenty six interim analysis, I think at least implies that enrollment rates continue to pick up. And I mean, you're seeing that trajectory in recent weeks, recent months as far as that curve continuing to steepen? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:15:19Yes, absolutely. And from the last earnings call, we're definitely seeing an encouraging uptick. Chase KnickerbockerSenior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC00:15:28Got it. That's it for me. Thanks. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:15:30Great. Thanks, Chase. Operator00:15:32Your next question comes from Thomas Flaten with Lake Street. Please go ahead. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:15:38Yes. Hey, thanks for taking another question. Just back to preeclampsia real quick. The Part two and three, those are those studies will be primarily based out of South Africa or are you thinking that there's going to be a U. S. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:15:52Component of those which would necessitate IND filing? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:15:56So part, the parts two and part three are still part of the same protocol. And so our collaborators will not need to go back for regulatory clearance. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:16:08And at some point will you expand the study and if so when into The U. S? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:16:13We do plan in the future to expand this to The U. S. And global and we'll more to share at a later date. Right now again the focus is you're getting the Part 1a and then moving into Part 1b as well as Parts two and then three hopefully. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:16:30Got it. Appreciate it. Thank you. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:16:32Yes. Thanks, Thomas. Operator00:16:35Thank you. There are no further questions at this time. I would like to turn the call back to Mr. Rick Puls. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:16:43All right. In closing, we're very encouraged by our steady progress and clear momentum across both the preeclampsia and stroke programs. We look forward to sharing upcoming key milestones including the top line results from our preeclampsia proof of concept trial and the interim analysis from our stroke program. We thank our dedicated team, investigators and importantly our patients and their families for the continued trust and commitment. Please also mark your calendars from May 28 at eight a. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:17:08M. Eastern Time for our preeclampsia KOL event. We'll be sending out the call in details via press release early next week. As always, we appreciate the ongoing support of our shareholders and look forward to updating you further in the months ahead. Thank you again for joining our call today. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:17:24This concludes our call. Operator00:17:27Ladies and gentlemen, you may now disconnect.Read moreParticipantsExecutivesRick PaulsPresident and Chief Executive OfficerScott KellenCFO & SecretaryAnalystsThomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLCMatthew CaufieldVP - Senior Healthcare Analyst at H.C. Wainwright & Co.Chase KnickerbockerSenior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLCPowered by Key Takeaways Preeclampsia Phase 2 update: Part 1a is nearing target dose selection with preliminary top-line data on safety, blood pressure reduction, and uterine/placental blood flow expected between mid-June and July. Novel preeclampsia therapy: DM199 is the only investigational treatment in pregnant women with preeclampsia, and a KOL event on May 28 will educate stakeholders on the disease and current Phase 2 trial design. Stroke program enrollment: REMEDY-2 enrollment has reached 20–25% toward the 200-patient interim analysis, with site engagement initiatives and a new stroke neurologist driving momentum toward a first-half 2026 read-out. Q1 financials: Cash and investments stood at $37.3 million, providing runway into Q3 2026; net cash used in operations was $7.1 million, and R&D spend rose to $5.7 million as clinical activities expand. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallDiaMedica Therapeutics Q1 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipants Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) DiaMedica Therapeutics Earnings HeadlinesHC Wainwright Reaffirms "Buy" Rating for DiaMedica Therapeutics (NASDAQ:DMAC)May 31 at 1:19 AM | americanbankingnews.comWith 39% ownership, DiaMedica Therapeutics Inc. (NASDAQ:DMAC) insiders have a lot riding on the company's futureMay 28, 2025 | finance.yahoo.comWatch This Robotics Demo Before July 23rdJeff Brown, the tech legend who picked shares of Nvidia in 2016 before they jumped by more than 22,000%... Just did a demo of what Nvidia’s CEO said will be "the first multitrillion-dollar robotics industry."June 3, 2025 | Brownstone Research (Ad)DiaMedica Therapeutics Announces Key Opinion Leader Webinar on DM199 (Rinvecalinase Alfa) for the Treatment of PreeclampsiaMay 20, 2025 | finance.yahoo.comEarnings call transcript: DiaMedica Therapeutics Q1 2025 earnings beat expectationsMay 15, 2025 | investing.comDiaMedica Therapeutics Inc. (DMAC) Q1 2025 Earnings Call TranscriptMay 15, 2025 | seekingalpha.comSee More DiaMedica Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like DiaMedica Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on DiaMedica Therapeutics and other key companies, straight to your email. Email Address About DiaMedica TherapeuticsDiaMedica Therapeutics (NASDAQ:DMAC), a clinical stage biopharmaceutical company, focuses on improving the lives of people suffering from serious diseases with a focus on acute ischemic stroke. Its lead candidate is DM199, a pharmaceutically active recombinant form of the human tissue kallikrein-1 protein, which is in Phase II/III trials for the treatment of acute ischemic stroke, as well as that is in Phase 2 to treat cardio-renal disease. The company also develops DM300, which is in preclinical stage for the treatment of severe inflammatory diseases. In addition, it develops treatment for neurological disease. The company was formerly known as DiaMedica Inc. and changed its name to DiaMedica Therapeutics Inc. in December 2016. 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PresentationSkip to Participants Operator00:00:00Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter twenty twenty five Conference Call. An audio recording of the webcast will be available shortly after the call today on DiaMedica's website at www.diamedica.com in the Investor Relations section. Before DiaMedica proceeds with its remarks, please note that the company will be making forward looking statements on today's call. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these statements. More information, including factors that could cause actual results to differ from projected results, appears in the section entitled Cautionary Note Regarding Forward Looking Statements in the company's press release issued yesterday and under the heading Risk Factors in the company's most recent annual report on Form 10 ks and most recent quarterly report Form 10 Q. Operator00:01:00DiaMedica's SEC filings are available on the SEC's website, www.sec.gov, and on its website, DiaMedica.com. Please also note that any comments made on today's call speak only as of today, 05/14/2025, and may no longer be accurate at the time of any replay or transcript rereading. DiaMedica disclaims any duty to update its forward looking statements. Following the prepared remarks, the phone lines will be open for questions. I would now like to turn you over to your host for today's call, Mr. Operator00:01:38Rick Pauls, DiaMedica's President and Chief Executive Officer. Mr. Pauls? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:01:45Thank you, operator. Hello, everyone, and welcome to our first quarter twenty twenty five conference call. I am joined this morning by Scott Kellen, our Chief Financial Officer. Doctor. Lorianne Mascioka is currently on short term medical leave and we hope she gets well soon. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:02:00We're happy to be here today to update you on the progress on our two clinical development programs. It has only been a short interval since our last update, thus I will keep my remarks brief. That said, I'm pleased to report that we continue to make substantial progress in both of our clinical development programs. I'll start with an update on our preeclampsia program. Building upon the significant accomplishments of this program within a very short timeframe, as we discussed in March, we're pleased to be able to disclose that we believe Part 1a of our Phase two investigator sponsored preclampsia trial is very close to identifying a target dose, to move forward within in Part 1b. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:02:41Dose selection will be guided primarily by a few key data points, which we expect to be sharing in our upcoming preliminary top line results from the Part 1a proof of concept portion of the trial. These key data points include: one, safety and tolerability, including results of a placental transfer analysis Two, the amount of decrease in systolic and diastolic blood pressure levels. And three, changes in uterine and placental blood flow as assessed by the Doppler ultrasound measurement of the Uterine Artery Pulcability Index. This measure is important as reductions in the pulsatility index may suggest decreased downstream resistance and improved uterine and placental blood flow, which could also be an indication of disease modifying. Currently we expect to be in a position to release those preliminary top line results between the second half of June and the July. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:03:39The final timing will be primarily dependent on the schedules at the outside laboratories running the various tests, including the pharmacodynamic biomarkers and the assay, which will be used to determine if DM199 crosses the placental barrier. One additional update. May is preeclampsia awareness month, and we will be sponsoring a preeclampsia key opinion leader call on May 28 at 8AM Eastern. Compared to other therapeutic areas like oncology, which have advanced more rapidly in recent years, the treatment of pregnancy complications remains outdated and is not well understood. No FDA approved treatments exist for preeclampsia despite the growing burden of this disease. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:04:24To our knowledge, DM199 is the only novel agent currently being studied in pregnant women with preeclampsia. With this KOL event, we will continue our work to educate investors, physicians, and other interested parties on preeclampsia as a disease and the current state of treatment. With this background, we will also discuss the design of our current Phase two trial of DM199 in preeclampsia. Turning briefly to our stroke program. Enrollment is moving ahead steadily. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:04:54We're pleased to announce that participant enrollment now is between the twentieth and twenty fifth percentile mark of patients enrolled for the interim analysis. Our next enrollment update will be at the fiftieth percentile mark. We believe that our efforts over the past year to engage with sites to promote communications between the sites and to simplify study logistics have been important in driving the recent uptick in enrollment. Accordingly, we reiterated our guidance that the interim analysis on those first two hundred participants will be completed in the first half of twenty twenty six. I would also note for you that we have engaged an experienced stroke neurologist to support site engagement during Lori Ann's leave in order to maintain our enrollment momentum in the REMEDY two trial. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:05:43This individual has spent over ten years treating stroke patients at a major US research center and also has five years of recent biotech drug development experience. He has been doing a tremendous job connecting with and maintaining our relationships with sites and supporting our recent enrollment momentum. Now I'd like to hand the call over to Scott Kellen to review this quarter's financial results. Scott KellenCFO & Secretary at DiaMedica Therapeutics00:06:06Thanks Rick, and good morning everyone. As the operator mentioned, we announced our first quarter twenty twenty five financial results and filed our quarterly report on Form 10 Q yesterday after the markets closed. These documents are both available on either the DiaMedica or the SEC websites. As of 03/31/2025, we reported a total combined cash and investments of 37,300,000.0 current liabilities of $4,700,000 and working capital of $32,800,000 This compares to a total combined cash and investments of $44,100,000 5 point 4 million dollars in current liabilities and $39,200,000 in working capital as of 12/31/2024. The decreases in combined cash and investments and in working capital were due primarily to the net cash used to fund our operations. Scott KellenCFO & Secretary at DiaMedica Therapeutics00:07:02Our net cash used in operating activities for the first quarter of twenty twenty five was $7,100,000 compared to $6,700,000 for the first quarter of twenty twenty four. The increase in cash used in operating activities resulted primarily from our increased net loss, partially offset by changes in operating assets abilities occurring during the current year period. We anticipate that our current cash and investments provides us a runway into Q3 of twenty twenty six. Our research and development expenses increased to $5,700,000 for the three months ended 03/31/2025, up from 3,700,000.0 for the three months ended 03/31/2024. The increase was due primarily to cost increases resulting from the continuation of our REMEDY two clinical trial, including our global expansion, increased manufacturing development activity, and the expansion of our clinical team during 2024. Scott KellenCFO & Secretary at DiaMedica Therapeutics00:08:05Now these increases were partially offset by cost reductions related to in use study work performed and completed in the prior year period. We expect that our R and D expenses will moderately increase in future periods relative to our recent prior periods, as we continue our REMEDY two trial, including the global expansion and our continued expansion of our DM199 clinical development program in preeclampsia. Our general and administrative expenses were $2,500,000 and $2,100,000 for the three months ended 03/31/2025 and 2024 respectively. This increase resulted primarily from additional non cash share based compensation expense recognized as a result of the approval of an extension of the post termination exercise period for stock options held by a retiring member of our Board of Directors. We expect G and A expenses to remain steady in future periods as compared to recent prior periods. Scott KellenCFO & Secretary at DiaMedica Therapeutics00:09:06Our net other income was $443,000 for the three months ended 03/31/2025, compared to 597,000 for the three months ended 03/31/2024. This decrease was driven by reduced interest income recognized during the current year period related to lower average marketable securities balances during the current year period as compared to the prior year period. With that, let me ask the operator to open the lines for questions. Operator00:09:38Thank you so much. Ladies and gentlemen, we will now begin our question and answer session. And And your first question comes from Thomas Flaten with Lake Street. Please go ahead. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:10:10Good morning. I appreciate taking the questions. Hey Rick, just to clarify, the laboratory test results that seem to be the variable in terms of readout between June and July. Is that primarily the test for DM199 crossing the placental barrier so in the umbilical cord or is there something else there that we should be aware of? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:10:31Yes, Thomas. Yes, absolutely. So that's the main item is going to be the placental transfer. So we have an assay that we're just having finalized in terms of getting to lower limits of detection. And so it's just a question of time for them to run it. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:10:47We want to at least give a range today in terms of when we anticipate the results. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:10:52Makes sense. And then I see you mentioned that you're expecting to start Part 1b in Q3. What are the triggers for Part two and three? So the expected management and the fetal growth restriction components of the study. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:11:08So I'll start off with the fetal growth restriction. So if we see dilation of the intrauterine arteries, our investigators are prepared to move ahead with that cohort and then we'll have more to talk about the part two when we daylight the results here in the coming weeks. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:11:29Got it. Excellent. I appreciate you taking the questions. Thank you. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:11:35Thanks Thomas. Operator00:11:38Your next question comes from Matthew Caulfield with H. C. Wainwright. Please go ahead. Matthew CaufieldVP - Senior Healthcare Analyst at H.C. Wainwright & Co.00:11:44Hi, good morning, guys. Thanks for taking our question. I was wondering if you could speak to anticipated read through or any derisking between the initial preeclampsia data and how that profile could translate to AIS development and the REMEDY two trial? Thanks again. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:12:02Sure. I mean, I'll start off by saying that these are definitely two very unique indications, but will add that a positive effect here in preeclampsia will just be another confirmation that this protein is active. And I would also mention around that we've previously talked about the fact that there are two forms of this protein in Asia that are being used. So the form of the protein isolated from human urine that today is treating close to a million patients per year for acute ischemic stroke. And then there's also form the protein isolate from pig pancreas in both Japan and China. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:12:42And we've been able to track down about 10 publications with that form of the protein to treat preeclampsia. So I think it will just be very encouraged and that we have an active protein and what we're seeing in some of the validation rationale for going into both of these indications is the, what we'll call the crude forms in Asia today. Matthew CaufieldVP - Senior Healthcare Analyst at H.C. Wainwright & Co.00:13:05Thanks a lot. Appreciate guys. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:13:08Thank you. Operator00:13:10Your next question comes from Chase Knickerbocker with Craig Hallum. Please go ahead. Chase KnickerbockerSenior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC00:13:17Good morning. Thanks for taking the questions. Rick, just on stroke, be good to kinda get some incremental details on, on enrollment. I mean, maybe just kinda starting out with those high volume or potential high volume centers. You know, can you kinda give us an update on what percentage of kind of those high volume accounts are now, at that one to two per month that you want to see? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:13:43I would add that as we had kind of talked on past calls, we really did think that there would be a small number of sites in particular in The U. S. That would drive enrollment. And as we're starting to build some momentum that's clearly what we're starting to see. So some of these high enrolling sites are seeing the one to two patients per site per month. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:14:04And so we're working on building momentum and then really working hard on some of those other sites to expand the relationship here to encourage. But I say currently we are above our plan here now and we're encouraged with momentum that's being built. Chase KnickerbockerSenior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC00:14:23So maybe just an update on overall centers as well as, know, again, it's only been a couple months here, have we expanded that past 30? Then maybe on the geographic footprint of those centers, have we started to see some international enrollment come in? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:14:39Yes. So we're currently in mid-30s and keeping in mind that there are sites now that are not performing that we're shutting down. And so we're really again focusing on the high enrolling sites. We also have sites in Georgia that have been performing very well. That's where that is the country of Georgia. Chase KnickerbockerSenior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC00:14:59Yeah, yeah, got it. And just kind of I guess summon all this up. First half twenty six interim analysis, I think at least implies that enrollment rates continue to pick up. And I mean, you're seeing that trajectory in recent weeks, recent months as far as that curve continuing to steepen? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:15:19Yes, absolutely. And from the last earnings call, we're definitely seeing an encouraging uptick. Chase KnickerbockerSenior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC00:15:28Got it. That's it for me. Thanks. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:15:30Great. Thanks, Chase. Operator00:15:32Your next question comes from Thomas Flaten with Lake Street. Please go ahead. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:15:38Yes. Hey, thanks for taking another question. Just back to preeclampsia real quick. The Part two and three, those are those studies will be primarily based out of South Africa or are you thinking that there's going to be a U. S. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:15:52Component of those which would necessitate IND filing? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:15:56So part, the parts two and part three are still part of the same protocol. And so our collaborators will not need to go back for regulatory clearance. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:16:08And at some point will you expand the study and if so when into The U. S? Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:16:13We do plan in the future to expand this to The U. S. And global and we'll more to share at a later date. Right now again the focus is you're getting the Part 1a and then moving into Part 1b as well as Parts two and then three hopefully. Thomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLC00:16:30Got it. Appreciate it. Thank you. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:16:32Yes. Thanks, Thomas. Operator00:16:35Thank you. There are no further questions at this time. I would like to turn the call back to Mr. Rick Puls. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:16:43All right. In closing, we're very encouraged by our steady progress and clear momentum across both the preeclampsia and stroke programs. We look forward to sharing upcoming key milestones including the top line results from our preeclampsia proof of concept trial and the interim analysis from our stroke program. We thank our dedicated team, investigators and importantly our patients and their families for the continued trust and commitment. Please also mark your calendars from May 28 at eight a. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:17:08M. Eastern Time for our preeclampsia KOL event. We'll be sending out the call in details via press release early next week. As always, we appreciate the ongoing support of our shareholders and look forward to updating you further in the months ahead. Thank you again for joining our call today. Rick PaulsPresident and Chief Executive Officer at DiaMedica Therapeutics00:17:24This concludes our call. Operator00:17:27Ladies and gentlemen, you may now disconnect.Read moreParticipantsExecutivesRick PaulsPresident and Chief Executive OfficerScott KellenCFO & SecretaryAnalystsThomas FlatenSenior Research Analyst at Lake Street Capital Markets, LLCMatthew CaufieldVP - Senior Healthcare Analyst at H.C. Wainwright & Co.Chase KnickerbockerSenior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLCPowered by